Cleared Traditional

VENUS FLOW

K033665 · Heraeus Kulzer, Inc. · Dental
Dec 2003
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K033665 is an FDA 510(k) clearance for the VENUS FLOW, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 30, 2003, 39 days after receiving the submission on November 21, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K033665 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2003
Decision Date December 30, 2003
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690